Bepotastine Ophthalmic
Bepotastine ophthalmic is an antihistamine eye drop used to relieve itching caused by allergic conjunctivitis (eye allergies).
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 7 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Bepotastine Ophthalmic: Patient Information Guide
A plain-language walkthrough of Bepotastine Ophthalmic — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Bepotastine ophthalmic solution is an antihistamine eye drop approved to treat eye allergy symptoms.
- Bepotastine Besilate Ophthalmic Solution 1.5% is indicated for the treatment of itching associated with the signs and symptoms of allergic conjunctivitis (eye allergies caused by allergens such as pollen, dust, or pet dander).
⚙️How it works▾
Bepotastine is a topically acting antihistamine — it works directly in the eye. It blocks H1 receptors, which are the sites histamine binds to in order to trigger itching and irritation. It also helps prevent mast cells (immune cells in the eye tissue) from releasing histamine in the first place. By working on both steps, it reduces allergic eye itch at the source rather than just masking symptoms.
💊How it's taken▾
Bepotastine Besilate Ophthalmic Solution is given as one drop into the affected eye or eyes twice a day. Always remove contact lenses before instilling the drops and wait at least 10 minutes before reinserting them.
- Apply to the affected eye(s) only — or both eyes, as directed by your prescriber.
- Do not use while wearing contact lenses.
- Follow your prescriber's instructions for how long to continue treatment.
🤒Side effects — in detail▾
Most people tolerate bepotastine eye drops well. The most commonly reported side effects include:
- A mild taste in the mouth after putting in the drops — this happens in about 1 in 4 people and is generally harmless.
- Eye irritation
- Headache
- Nasopharyngitis (runny nose or mild throat irritation)
Rarely, serious hypersensitivity reactions (allergic reactions) have been reported. Seek immediate medical attention if you develop itching, a body rash, or swelling of the lips, tongue, or throat after using this medication.
⚠️Warnings & precautions▾
- Bottle contamination: Never touch the dropper tip to your eye, eyelid, or any surface. Keep the cap on tightly when not in use. A contaminated dropper can introduce bacteria and cause an eye infection.
- Contact lens wearers: Remove soft contact lenses before using the drops. The preservative benzalkonium chloride can be absorbed into soft lenses. Wait at least 10 minutes after using the drops before reinserting your lenses.
- Not for contact lens irritation: This product is intended for allergic conjunctivitis, not for irritation caused by contact lenses themselves.
- Hypersensitivity: Rare but serious allergic reactions have been reported. Stop use and get medical help right away if you notice itching, rash, or swelling of the mouth, lips, or throat.
🔀What it interacts with▾
Based on available data, bepotastine eye drops have a low potential for drug interactions when used as eye drops, as very little of the medication enters the bloodstream.
- Bepotastine is minimally processed by the liver's CYP450 enzyme system, meaning it is unlikely to meaningfully affect how most other medications are metabolized.
- Always tell your doctor and pharmacist about all medications, vitamins, and supplements you take, as individual situations can vary.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Allergy to bepotastine or any ingredient: Do not use if you have had a prior allergic reaction to this product.
- Pregnancy: There are no human safety data for use during pregnancy. Talk to your doctor about the risks and benefits before using.
- Breastfeeding: It is not known whether bepotastine passes into human breast milk when used as an eye drop. Discuss with your doctor before using.
- Children under 2 years: Safety and effectiveness have not been established in this age group.
- Children 2–10 years: Effectiveness data in this age group was extrapolated from older children and adults, not studied directly.
- Older adults: No meaningful differences in safety or effectiveness have been observed compared to younger patients.
- Contact lens wearers: Remove lenses before use and wait 10 minutes before reinserting.
🔬Pharmacokinetics — how your body processes it▾
After putting bepotastine eye drops in both eyes, a small amount is absorbed into the bloodstream, peaking about 1 to 2 hours after instillation. Blood levels drop quickly and are essentially undetectable by 24 hours after the dose in nearly all people studied. The drug is about 55% bound to proteins in the blood and is minimally broken down by the liver. Roughly 75–90% of absorbed bepotastine is eliminated from the body unchanged through the urine.
📦How to store it▾
Store at 15° to 25°C (59° to 77°F).
📄 Written from Bepotastine Ophthalmic’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Bepotastine Ophthalmic — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is this eye drop supposed to do? ▾
Why do I taste something weird after I put in the drops? ▾
Can I put the drops in while I'm wearing my contact lenses? ▾
What side effects should I actually be worried about? ▾
Is it safe to use during pregnancy or while breastfeeding? ▾
How do I keep the drops from getting contaminated? ▾
Is Bepotastine Ophthalmic available over the counter? ▾
When was Bepotastine Ophthalmic first available? ▾
Who makes Bepotastine Ophthalmic? ▾
💬 Answers drafted from Bepotastine Ophthalmic’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Bepotastine Ophthalmic comes
Bepotastine Ophthalmic is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Eye drops
How this form is used
- Bepotastine Besilate Ophthalmic Solution is used to treat itching associated with allergic conjunctivitis.
- Bepotastine Besilate Ophthalmic Solution 1.5% is indicated for itching associated with the signs and symptoms of allergic conjunctivitis.
- Bepotastine Besilate Ophthalmic Solution: instill one drop into the affected eye(s) twice a day.
- Bepotastine Besilate Ophthalmic Solution: remove contact lenses before instilling the drops.
- Bepotastine Besilate Ophthalmic Solution: wait at least 10 minutes after instillation before reinserting contact lenses.
- Bepotastine Besilate Ophthalmic Solution: do not touch the dropper tip to your eye, eyelid, or any surface; keep the bottle tightly closed when not in use.
📊 Bepotastine Ophthalmic across the U.S. market
How Bepotastine Ophthalmic appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Bepotastine Ophthalmic is used
A general measure of how commonly Bepotastine Ophthalmic is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Bepotastine Ophthalmic is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Bepotastine Ophthalmic prescribed? Of the 1,596 medications we measure, Bepotastine Ophthalmic ranks #934 by Medicaid prescriptions — more than 41% of them.
Utilization by Bepotastine Ophthalmic product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
bepotastine besilate 15 MG/ML Ophthalmic Solution
Summed across the 11 of 17 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 863038
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Bepotastine Ophthalmic, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 11 of 17 listed Bepotastine Ophthalmic NDCs with Medicaid activity.
🔍 Compare Bepotastine Ophthalmic products
A representative set of FDA-listed product records for Bepotastine Ophthalmic — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Eye drops | ||||
| 15 mg/mL | Ophthalmic | Alembic Pharmaceuticals Inc. | ANDA | View NDC → |
| 15 mg/mL | Ophthalmic | Alembic Pharmaceuticals Limited | ANDA | View NDC → |
| 15 mg/mL | Ophthalmic | Apotex Corp. | ANDA | View NDC → |
| 15 mg/mL | Ophthalmic | Bausch & Lomb Americas Inc. × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 15 mg/mL | Ophthalmic | Bausch & Lomb Incorporated | NDA | View NDC → |
| 15 mg/mL | Ophthalmic | Bausch & Lomb Incorporated | NDA AUTHORIZED GENERIC | View NDC → |
| 15 mg/mL | Ophthalmic | Mylan Pharmaceuticals Inc. × 2 listings | ANDA | View NDC → |
| 15 mg/mL | Ophthalmic | Somerset Therapeutics, LLC × 2 listings | ANDA | View NDC → |
Showing 11 of 11 products — FDA National Drug Code Directory. See every product, package size and price: browse all 11 Bepotastine Ophthalmic NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Bepotastine Ophthalmic — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Bepotastine Ophthalmic in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Bepotastine Ophthalmic went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 863035 1 dose form · 1 strength
-
Dose form (SCDF) Ophthalmic Solution RxCUI 863037In current FDA listingsClinical drug / strength (SCD) besilate 15 MG/MLRxCUI 863038
Look up RxCUI 863035 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Bepotastine Ophthalmic is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Bepotastine Ophthalmic belongs to the Histamine-1 Receptor Antagonist class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 7 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Bausch & Lomb Americas Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.